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Trial registered on ANZCTR
Registration number
ACTRN12610000245099
Ethics application status
Not yet submitted
Date submitted
15/03/2010
Date registered
24/03/2010
Date last updated
24/03/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of Parecoxib on postoperative liver function in Patients Undergoing hepatectomy of hepatic carcinoma
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Scientific title
Effects of Parecoxib, a selective cyclooxygenase-2 inhibitor,on liver function in Patients Undergoing hepatectomy of hepatic carcinoma: A Double-Blind, Randomized, Comparative Study
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Secondary ID [1]
1523
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None
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Universal Trial Number (UTN)
None
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Trial acronym
None
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatic carcinoma resection among crirhotic patients
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Condition category
Condition code
Anaesthesiology
257112
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0
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Anaesthetics
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Cancer
257113
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0
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1)Target controlled infusing(TCI) of propofol concentration of 3-6 ug/min, the individual patient’s dose is base on the clinical variables. 2)anaesthic administered from 30 minutes before commencement of surgery until completion of surgery. 3) the mode of administration: intravenous infusion .4) parecoxib 50mg intravenous infusion before cut skin and again after 6 hours . 5) Patient-controlled intravenous analgesia(PCIA) sufentanil will be administered for 2 days(background infusion is 2ml/h(sufentanil 2.4ug/h),bolus does is 2ml(sufentanil 2.4ug))
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Intervention code [1]
256146
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Treatment: Drugs
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Comparator / control treatment
1) the mode of administration: intravenous infusion .2) saline solution (as placebo)10ml intravenous infusion before cut skin and again after 6 hours. 3) Patient-controlled intravenous analgesia(PCIA) sufentanil will be administered for 2 days(background infusion is 2ml/h(sufentanil 2.4ug/h),bolus does is 2ml(sufentanil 2.4ug))
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Control group
Placebo
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Outcomes
Primary outcome [1]
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postoperative liver fuctions and hepatocyte injury defined by peak alanine-aminoteansferase(ALT) and aspartate-aminoreaansferrase(AST) levels in serum analysis.
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Assessment method [1]
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Timepoint [1]
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on operation day, postoperative day 1,3,7
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Primary outcome [2]
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postoperative pain levels are measured by numerical rating scale(RNS) pain scores,dose and frequency of rescues analgesic (hypodermic injection of morphine) use
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Assessment method [2]
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Timepoint [2]
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on operation day, postoperative day 1,3,7
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Secondary outcome [1]
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inflammatory stress is measured by serum cytokine tumor necrosis factor-a(TNF-a) and serum Interleukin-1(IL-1)
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Assessment method [1]
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Timepoint [1]
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on operation day,postoperative day 1,3,7
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Eligibility
Key inclusion criteria
1.elective liver resection 2. American Society of Anesthesiologists (ASA) physical status 2-3 patients 3.Primary liver cancer patients who had history of hepatitis B related cirrhosis 4.undergoing combine general and epidural anesthesia
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1contradictions of epidural puncture including coagulate disorder (prothrombin time (PT) longer than 15 sec or/and blood platelets count less than 10,000 ).
2.tumor size too small or too large(longitude of tumor was beyond 3-8 cm ) or estimated blood loss was large than 1000 cc.
3.Individuals in whom the regional block failed and surgery was performed under general anesthesia alone were also withdrawn from the study..
4.Patients with a known allergy to NSAIDs
5.Patients who had received chemotherapy and radiation prior to surgery
6.patients who with a history of peptic ulceration, or renal, cardiac, endocrine
7. Patients who had received Non steroidal anti-inflammatory drugs (NSAIDs) within 14 days before enrollment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
ASA II-III physical status patients who underwent hepatectomy surgery for resection the hepatic neoplasms who had history of hepatitis B related cirrhosis under combined general and epidural anesthesia were enrolled after signed an approved information consent. Sequentially-Numered,Opaque,Sealed Envelopes(SNOSE) were used as allocation concealment method.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes that were maintained in opaque envelopes until the anesthesia began
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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shanghai
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University
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Address [1]
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No.255 Changhai Road,shanghai,
200438,China
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Country [1]
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China
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Primary sponsor type
Individual
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Name
jinmin zhang
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Address
No.255 Changhai Road,shanghai,
200438,China
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Country
China
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Secondary sponsor category [1]
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Individual
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Name [1]
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liqun yang
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Address [1]
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No.255 Changhai Road,shanghai,
200438,China
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Country [1]
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China
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Ethics Committee of the 3rd Affillated Hospital the 2nd Military Medical University
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Ethics committee address [1]
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No.255 Changhai Road,shanghai, 200438,China
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Ethics committee country [1]
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China
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Date submitted for ethics approval [1]
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15/03/2010
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Approval date [1]
258673
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Ethics approval number [1]
258673
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Summary
Brief summary
Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction. Nonsteroidal anti-inflammatory drugs (NSAIDs) may prevent or reduce hyperalgesia, inhibit inflammation, and reduce pain by reducing the synthesis of prostaglandins in response to tissue damage caused by surgery. There are some hepatic side effects reported by several spontaneous reports. While evidence from animal studies has shown that administration of COX-2 inhibitors minimize hepatic necrosis in chloroform induced liver injury. The aim of this study is to compare the effects of parecoxib, flurbiprofen and placebo in patients undergoing hepatectomy of hepatic carcinoma. Since Pringle’s maneuver are commonly applied by most of surgeons in our center which also cause an inevitable liver damage perioperatively, therefore providing us an ideal clinic model of hepatic I/R injury. The pain under mobilization registered via a visual analogue score. The injury of hepatocytes is evaluated by measuring plasma levels of alanine transaminase (ALT),aspartate aminotransferase(AST),interleukin 1 (IL-1), and tumor necrosis factor alpha (TNFa) levels. postoperative recovery is evaluated by hospital stay and complications. Liver resection may require hepatic inflow occlusion to diminish intraoperative blood loss,thus may result in transient ischemia followed by reperfusion(I/R),which may initiate liver injury and lead to postoperative liver dysfunction.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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jinmin zhang
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Address
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Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University,No.255 Changhai Road,shanghai, 200438,China
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Country
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China
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Phone
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+8621-81875231
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Fax
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+8621-81875231
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Email
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[email protected]
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Contact person for scientific queries
Name
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jinmin zhang
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Address
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Department of Anaesthesia & Intensive Care the 3rd Affillated Hospital the 2nd Military Medical University,No.255 Changhai Road,shanghai, 200438,China
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Country
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China
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Phone
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+8621-81875231
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Fax
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+8621-81875231
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Email
5111
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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